The U.S. Food and Drug Administration (FDA) just announced that a Consent Decree of permanent injunction was filed yesterday enjoining KV Pharmaceutical Company, its subsidiaries ETHEX Corporation and Ther-Rx Corporation, and its principal officers, from making and distributing adulterated and unapproved drugs.
This is the most recent in an extensive series of incidents regarding KV Pharmaceuticals and its subsidiaries. Early last month, ETHEX expanded a prior generic drug recall. Like other ETHEX recalls from the previous several months, the expanded recall was necessary because of manufacturing problems and involved a variety of medications, all of which had been issued at the wholesale level and were expanded to the retail level. The recall was implemented because the products might have been manufactured under conditions that did not sufficiently comply with the FDA’s current Good Manufacturing Practice (cGMP) regulations.
In January, KV Pharmaceuticals suspended manufacturing and shipping of all of its products, including those made under the ETHEX name. That announcement followed an inspection that began in December by the FDA of the company’s operations and inventory. Because of the manufacturing problems cited by the FDA, ETHEX issued several recalls last year. In January, ETHEX issued a recall of its prescription infant vitamins and prescription iron supplements; also, problems at KV Pharmaceuticals prompted ETHEX to recall scores of generic drugs that might have been defective.
In December, the drug maker recalled a single lot of Hydromorphone HCl 2 mg tablets because some may have been oversized. In November, the company initiated a nationwide voluntary recall of five generic drugs due to the potential for oversized drugs. That action followed an October recall of three lots of potentially oversized Dextroamphetamine Sulfate. In June, ETHEX recalled several lots of 60 mg and 30 mg morphine extended release tablets that may have been oversized.
Now, the injunction against KV and the other defendants, once entered by the court, will prevent them from manufacturing and shipping drugs until the firm obtains FDA approval and will remain in place until the defendants sustain continuous—five-year—compliance with FDA’s cGMP and new drug approval requirements. The Consent Decree also enjoins KV’s officers David A. Van Vliet, president and chief executive officer; Rita E. Bleser, president of the pharmaceutical division; Jay S. Sawardeker, vice president of corporate quality; and Marc S. Hermelin, former chief executive officer and a member of KV’s Board of Directors, from manufacturing and distributing any drug at or from KV’s facilities until such time that the company’s procedures and products are brought into compliance with the law.
The FDA inspected KV between December 2008 and February 2009, and found that the company had significant cGMP violations and continued to manufacture unapproved drugs. “The FDA requires companies to manufacture drugs in accordance with the current good manufacturing practice standards and to comply with FDA approval requirements,” said Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research (CDER). “Consumers need to be confident that drugs meet our manufacturing requirements for identity, strength, purity, and quality, and have been evaluated by the FDA for safety and efficacy.”
Under the terms of the Consent Decree, the defendants cannot resume manufacturing and distributing drugs until both an independent expert and FDA officials conduct inspections of the facilities and certify compliance with the Federal Food, Drug, and Cosmetic Act (the Act), its implementing regulations, and the Decree. The Decree requires the defendants to destroy all drugs recalled between May 2008 and February 3, 2009; those drugs are currently in the defendents’ possession.
If the defendants fail to comply with any provision of the Decree, the Act, or FDA regulations, the FDA may order the firm to again stop manufacturing and distributing drugs, recall the products, or take other corrective actions. The Decree subjects the defendants to liquidated damages of $15,000 per day if they fail to comply with any of the Decree’s provisions, and the payment of an additional $15,000 per violation, up to $5 million annually. “The FDA will carefully monitor the provisions of this injunction against the KV Pharmaceutical Company to ensure compliance,” said Michael Chappell, the acting associate commissioner of FDA’s Office of Regulatory Affairs. “Companies should know that FDA will investigate and take action against other marketers of unapproved drugs.”